1. Field of the Invention
The invention relates to a medical device for use in the identification of oral pre-cancerous and cancerous conditions. More particularly, the present invention relates to an oral cancer screening device having an illumination source, a selector switch to enable the selection of a light source having a specific wavelength, an LED or laser diode at a distal end of the device, and a filter, an optical mixing element or diffuser, a beam shaper or a cover to protect the LED or laser diode.
2. Description of the Related Art
A considerable number of oral cancerous and precancerous tissue changes are not visually apparent. The difficulty in detecting early stages of oral cancer means that oral cancer has one of the worst survival rates of all cancers. Yet whenever oral cancer is detected and treated early, patient survival is better than those of most cancers. Unfortunately, patient survival 5 years after diagnosis has remained poor, with little improvement over the last 30 years (<50%), mainly because most cases of oral cancer are detected late (at stages III and IV) in the disease process.
The American Dental Association estimates that 60% of the U.S. population has an annual dental exam. This fact provides the potential to include cancer screenings in annual dental exams so that oral cancer can be detected in its early stages. Unfortunately, published studies indicate that currently less than 15% of those who visit a dentist regularly report having had an oral cancer screening.
It is now commonplace for women to get an annual Papanicolaou (PAP) smear for cervical cancer screening or a mammogram to check for breast cancer. These screening efforts have been possible due to public awareness of the value of catching cancers in their earliest forms as well as effective technologies for conducting the examinations. If dental examinations included screening patients for oral cancer, the early detection of oral cancer would increase and lives would be saved.
Oral cancer is an ideal cancer to identify early by screening. It is frequently preceded by an identifiable pre-malignant lesion and the progression from dysplasia typically occurs over a period of years. However, before oral cancer screening will be incorporated into the normal dental examination, the dentist must have available effective and efficient technologies for conducting the examinations
Accordingly, dentists need readily useable and economical tools for the early detection of cancerous changes in the mouth.